Blog
RSS FeedPosted by Michael Wonder on 18 Aug 2016
Portola Pharmaceuticals receives complete response letter from FDA for biologics license application for AndexXa (andexanet alfa)
17 August 2016 - Portola Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 17 Aug 2016
Esketamine receives breakthrough therapy designation from U.S. Food and Drug Administration for major depressive disorder with imminent risk for suicide
16 August 2016 - FDA action marks second breakthrough therapy designation for intranasal esketamine, highlighting its potential as treatment for patients ...
Posted by Michael Wonder on 17 Aug 2016
The FDA, Juno Therapeutics, and the ethical imperative of transparency
15 August 2016 - Despite deaths, investigational new drugs are still protected trade secrets of the manufacturer. ...
Posted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...
Posted by Michael Wonder on 11 Aug 2016
Heart of bureaucratic darkness
9 August 2016 - Why won’t the FDA make a decision on a muscular dystrophy drug? ...
Posted by Michael Wonder on 11 Aug 2016
The future of cardiovascular medicine from the regulatory perspective
10 August 2016 - For many years, the American public and the entire world have benefited from the U.S. FDAs’ regulatory ...
Posted by Michael Wonder on 10 Aug 2016
Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting
10 August 2016 - Sustol is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea ...
Posted by Michael Wonder on 09 Aug 2016
Cancer-drug ads vs. cancer-drug reality
9 August 2016 - Two days into a long-dreamed-of family vacation to Italy in August 2013, my wife, Ronna, became nauseated, ...
Posted by Michael Wonder on 08 Aug 2016
New FDA documents reveal history of breakthrough therapy designation for Epclusa
5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 ...
Posted by Michael Wonder on 08 Aug 2016
Merck announces U.S. FDA filing acceptance of new drug application for MK-1293, an investigational follow-on biologic insulin glargine
5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review. ...
Posted by Michael Wonder on 06 Aug 2016
The FDA approves first generic version of widely used influenza drug Tamiflu
On August 3, 2016, the U.S. FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication ...
Posted by Michael Wonder on 06 Aug 2016
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
5 August 2016 - The U.S. FDA today issued draft updated recommendations to help manufacturers determine when they are required to ...
Posted by Michael Wonder on 04 Aug 2016
Drugmakers split on whether to include interchangeability statement in biosimilar labels
3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major ...
Posted by Michael Wonder on 04 Aug 2016
Microbion Corporation announces FDA has granted fast track designation to MBN-101 for the adjunctive treatment of moderate and severe diabetic foot ulcer infections
3 August 2016 - Microbion today announced that the U.S. FDA has granted MBN-101 fast track designation for adjunctive treatment of ...